- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00863382
Comparison of External Event Recorders for Atrial Fibrillation Monitoring
May 4, 2012 updated by: Dhanunjaya Lakkireddy, MD, FACC
Comparison of External Event Recorders With Implantable Monitor for Post Atrial Fibrillation Monitoring: Assessment of Cost and Efficacy
Ablation of atrial fibrillation is a well established treatment method to restore normal sinus rhythm and eliminate the need for continued antiarrhythmic therapy and anticoagulation.
Absence of symptomatic and asymptomatic atrial fibrillation should be considered necessary for discontinuation of anticoagulation therapy.
Presently, recurrence of atrial fibrillation is usually determined with the use of a non looping event monitor which is typically used by the subject at the time of symptomatic arrhythmia.
This method does not detect asymptomatic atrial fibrillation.
Random asymptomatic recording can be added, but the chance for detecting recurrence of arrhythmia is not great.
Too frequently, the success rates of AF ablation procedures are inflated by insufficient follow up and patient's limited compliance in reporting and recording episodes of recurrent arrhythmias.
Often times, it is very inconvenient for patients to wear external event recorders.
Allergies to the sticky pads that are needed for most of the external monitoring devices continues to be a problem.
Implantable loop recorders have the advantage of detecting symptomatic and asymptomatic atrial fibrillation continuously.
They also offer the convenience of monitoring for up to 18 to 24 months without significant patient discomfort.
However, implantation and explantation of these devices involves a limited surgical procedure as well as considerable experience.
In this study we attempt to assess the differences in these two types of monitoring systems in assessing the long term efficacy of AF ablation.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All subjects who undergo radiofrequency ablation of paroxysmal AF.
Exclusion Criteria:
- Subjects with known allergy to sticky patches of event monitor
- Subjects with skin infection or other problems on the chest that interferes with monitor implantation
- Subjects who are scheduled for radiation therapy
- Subjects who are scheduled for therapeutic ultrasound (like lithotripsy)
- Subjects who are scheduled for MRI
- Subjects who are scheduled for a procedure that uses diathermy.
- Subjects, in the opinion of the investigator, are not suitable candidates for the study
- Subjects that do not have analog telephone line at home.
- Existing Cardiac Rhythm Management Device (e.g., pacemaker or ICD)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Standard Event Monitor
|
Standard Event Monitor
|
Active Comparator: 2
Sleuth recorder
|
Implantable Sleuth Recorder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
recurrence of atrial fibrillation
Time Frame: 6 months, 1 year, 2 years
|
6 months, 1 year, 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cost-effectiveness ratio (ICER) between the two technologies and the 95% confidence interval for the ICER
Time Frame: 6 months, 1 year, 2 years
|
6 months, 1 year, 2 years
|
percentage of patients whose Coumadin is stopped prematurely due to inappropriate assumption of rhythm control
Time Frame: 6 months, 1 year, 2 years
|
6 months, 1 year, 2 years
|
percentage of patients who develop symptoms of stroke or transient ischemic attacks during follow up
Time Frame: 6 months, 1 year, 2 years
|
6 months, 1 year, 2 years
|
cost differences in follow up care between the two groups
Time Frame: 6 months, 1 year, 2 years
|
6 months, 1 year, 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dhanunjuya Lakkireddy, MD, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Anticipated)
January 1, 2011
Study Completion (Anticipated)
January 1, 2012
Study Registration Dates
First Submitted
March 16, 2009
First Submitted That Met QC Criteria
March 17, 2009
First Posted (Estimate)
March 18, 2009
Study Record Updates
Last Update Posted (Estimate)
May 7, 2012
Last Update Submitted That Met QC Criteria
May 4, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11566
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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